The company said the drug's extended-release formula would make it harder to abuse, but crushing OxyContin pills made them a "drug du jour" for many abusers and forced the company to add anti-abuse mechanisms.

So why not require extended-release Zohydro to have updated abuse-deterrent properties?

The Road to Abuse-Deterrent Technology

Pleasure-seekers have found many ways to get extended-release opioid drugs to release their full punch all at once, instead of being doled out slowly over many hours. These pills can be crushed, chewed, or mixed with alcohol or other liquids to extract the active ingredient.

Some have even combined their opioids with anti-opioid agents, such as naltrexone, which block opioid receptors in the brain to send abusers into withdrawal rather than getting them high.

Last January, the FDA released a draft guidance that would require all new opioid drugmakers to incorporate these properties into their products. But that document has yet to be finalized.

Bob Twillman, PhD, director of policy and advocacy for the American Academy of Pain Management, said even if that guidance was in place, it's likely Zohydro would have been grandfathered because it was "well into the development process before abuse-deterrent technology became available."

Indeed, the drug was first developed in 2002 by Elan (which has now merged with Alkermes), and Zogenix acquired the U.S. rights in November 2007. The company presented Zohydro to the FDA advisory committee just one month before the agency issued its initial draft of the abuse-deterrent guidance.

In 2010, four years after it was fined, Purdue upgraded its OxyContin recipe to include abuse-deterrent mechanisms, and it requested that FDA block generic versions lacking those properties – which the FDA ultimately agreed to do, effectively giving Purdue extended patent protection.

The FDA said that unlike old OxyContin, the first incarnation of Opana wasn't pulled from the market for safety reasons, so generic formulations would be allowed.

"While FDA strongly supports a transition to abuse-deterrent opioids, we do not believe it is appropriate or feasible at this time to require all products in the class to be abuse-deterrent," Morgan Liscinsky, a spokesperson for the FDA, said in an email to the Journal-Sentinel/MedPage Today. "Rather, FDA will continue to take a product-by-product approach to regulatory decisions concerning the abuse-deterrent properties (or lack thereof) of opioid products."

In a statement to Journal Sentinel/MedPage Today, drugmaker Zogenix, of San Diego, said the company intends to develop an abuse-deterrent formulation of the drug and is "committed to advancing the program as rapidly as possible."

But during the FDA advisory committee hearing last December, a company spokesperson said an abuse-deterrent formulation of the drug is only in pre-clinical development and would be "several years away from the market."

Regardless of when the updated version comes to the clinic, the strategy of releasing one product first, followed by an upgrade, undoubtedly extends patent-protection on the drug, granting it additional years of exclusivity.

Twillman said his group is concerned about the lack of abuse-deterrent properties with Zohydro because it can put patients at "unnecessary risk if they chose to alter their medication."

"While we do not believe that every person using long-acting opioids needs to use tamper-deterrent products, we would prefer to see that all new opioid pain relievers incorporate these features," Twillman said.

David Juurlink, MD, PhD, director of pharmacology and toxicology at the University of Toronto, said even parties who typically disagree about the role of opioids in chronic pain "agree that abuse-deterrent products make sense."

"The FDA agrees too. Yet in Zohydro, they have granted approval to pure, high-dose hydrocodone in a formulation that is not abuse-deterrent," Juurlink said. "If the FDA was really interested in protecting the public, they would have said, 'No thanks. There's no therapeutic void here, and we have too many people dying of opioids in this country to justify approving Zohydro.'"

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